# KPL: Colonic Irrigation System

- Device class: 2; regulation: 21 CFR 876.5220; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 604 days (middle half 604–604)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 2
- 2004: 1
- 2005: 3
- 2007: 1
- 2010: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2022: 1

## Most-cited predicates
- K131852: HC-1 and HC-1 Classic (2014), cited by 3
- K003720: Angel of Water Colon Hydrotherapy System (2002), cited by 2
- K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) (2000), cited by 2
- K050112: Pro Fit Disposable Rectal Speculum, Models 8116 and 8117 (2005), cited by 1
- K970482: Transcom Colon Hydrotherapy Model HC-2000 (1997), cited by 1
- K973256: Jimmy John Iii Rectal Nozzle (1997), cited by 1
- K150381: Aqua Cleanse (2015), cited by 1
- K980868: GC Irrigator (1998), cited by 1
- K962259: Libbe Rectal Tube (Formerly a Yankauer Suction Tube) (1996), cited by 1
- K033149: Ultimate Professional Continuous Flow Colonic System (2004), cited by 1

Source page: https://510kreport.com/product-code/KPL
Data by year (CSV): https://510kreport.com/product-code/KPL.csv